TUXEDO-4
OFFICIAL TITLE: PHASE II STUDY OF TRASTUZUMAB-DERUXTECAN (T-DXD; DS-8201A) IN HER2-LOW BREAST CANCER PATIENTS PRESENTING WITH NEWLY DIAGNOSED OR PROGRESSING BRAIN METASTASES.
Breast cancer with brain metastases
II
27
12
Spain, Austria
Set-up
CLINICAL TRIAL DETAILS
THE PRIMARY OBJECTIVE IS TO ASSESS THE OVERALL RESPONSE RATE (ORR) ACCORDING TO RANO-BM CRITERIA. THE STUDY WILL ALSO ASSESS THE ORR ACCORDING TO RECIST V.1.1 FOR EXTRACRANIAL AND OVERALL LESIONS, THE BICOMPARTMENTAL BENEFIT RATE (SUM OF THE COMPLETE RESPONSE, PARTIAL RESPONSE AND STABLE DISEASE RATES), DURATION OF RESPONSE, TIME TO RESPONSE, BEST PERCENTAGE CHANGE IN TUMOR BURDEN, PROGRESSION FREE SURVIVAL, OVERALL SURVIVAL, SAFETY, QUALITY OF LIFE, AND NEUROCOGNITIVE AND NEUROLOGICAL FUNCTION.
TUXEDO-4 AT CLINICALTRIALS.GOV
TUMOR TYPE
PHASE
N
SITES
COUNTRY
STATUS
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TUXEDO-4 SITES
SPAIN
Vall d’Hebron Instituto de Oncología
SPAIN
Hospital Beata María Ana
SPAIN
Hospital Universitario Clínico San Cecilio de Granada
SPAIN
Hospital Universitario Reina Sofía
SPAIN
Hospital Universitari Dexeus
SPAIN
Hospital Clínico Universitario de Valencia
SPAIN
Hospital Universitario Basurto
SPAIN
Hospital Universitario Ramón y Cajal
SPAIN
Hospital Universitario Virgen del Rocío
SPAIN
Hospital Universitario San Juan Alicante
AUSTRIA
Medical University of Vienna
AUSTRIA
Salzburg Cancer research Institute-Center for Clinical Cancer and Immunology Trials (SCRI-CCCIT)